Manager, R&D Quality Risk Management III

Our client develops and commercializes therapies for hallucinations and delusions associated with Parkinson’s disease. Overview: Responsible for managing assigned Research and Development (R&D) Quality Risk Management activities, including assessment and quality control of our client's clinical trials' execution in a Good Clinical Practices (GCP) regulated environment. Additional areas of support include Drug Safety and Pharmacovigilance, Computer System Validation and Good Laboratory Practices (GLP). Candidate will be required to work closely with internal R&D teams and Contract Service Providers (CSPs) as clinical trials are designed and conducted. Will be required to identify emerging issues and compliance risks, measure performance metrics, and suggest opportunities for improvement for clinical trial related processes and procedures and contribute to (or lead efforts to) their implementation. Potential to coach and support junior associates in R&D Quality Risk Management (R&D QRM) department, where needed.  Responsibilities:

• Contribute to effective quality control and risk management of R&D procedures and processes.*
• Ensure the continuous improvement of clinical trial processes and associated*
• SOPs within Clinical Operations, trial monitoring, Data Management and Pharmacovigilance (PV).*
• Create new appropriate process and/or compliance indicators (semi-automated metrics and manual spot-checks) in order to reinforce adherence to internal processes and procedures and to identify areas for improvement.*
• Calculate, track and report such indicators on a continual basis.*
• Work in close collaboration with colleagues in R&D Quality Management, operational units in Drug Development (Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, vendors (CSPs) and partners in GMP QA).*
• Provide input on quality and compliance concerns and lead implementation of trial risk management strategies in support of clinical development teams, CROs, contractors and consultants.*
• Maintain and where needed update aspects of the R&D QRM framework, e.g. internal procedures, processes training modules and tools.*
• Lead the organization through QRM related changes, e.g. updates from ICH, regulatory guidances and business best practices.